Hypoparathyroidism
Conditions
Interventions
Experimental group:Strategic autologous transplantation of double inferior parathyroid glands
Control group:In situ preservation of 4 parathyroid glands
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) All patients aged 18-70 years with primary PTC or suspected PTC who underwent preoperative ultrasound and enhanced CT scan of the thyroid gland and whose diagnosis was confirmed by FNA cytology or histology. (2) Indications for total thyroidectomy: Based on the 2012 "Guidelines for the diagnosis and treatment of thyroid nodules and differentiated thyroid cancer" (Chinese version). Any of the following criteria should be met: (1) bilateral cancer foci; (2) highly invasive subtypes, such as hypercellular, columnar cell, diffuse sclerotic, and solid subtypes of PTC; (3) local and distant metastases requiring postoperative 131I treatment; (4) extra-glandular invasion (such as subcutaneous adipose tissue, muscle, trachea, esophagus, carotid artery, or mediastinal invasion); (5) primary foci >1 cm in diameter; (6) high risk factors for thyroid cancer; (7) isthmic PTC (6) High risk factors for thyroid cancer; (7) PTC in the isthmus; (8) Concomitant contralateral thyroid nodules; (9) Patients with positive BRAF mutation. (3) The indications for bilateral lymph node dissection in the central region are any of the following: (1) bilateral cancer foci; (2) T3 and T4 tumors; (3) lymph node metastasis in the lateral cervical region; (4) highly invasive subtype; (5) prelaryngeal and pre-tracheal lymph node metastasis; (6) lymph node enlargement in the contralateral central region detected on imaging or intraoperatively; (7) PTC in the isthmus; (8) tumor maximum diameter >1 cm; (9) patients with positive BRAF mutation; (10) patients with strong desire for more thorough desire. (4) The laboratory results before enrollment were compatible with surgical conditions and there were no contraindications to surgery. 5) no psychological, family, social, or geographic limiting factors that may affect program compliance and follow-up time. 6) Voluntary participation, signed informed consent, and willingness for long-term follow-up.
Exclusion criteria
Exclusion criteria: Those with one of the following conditions may not be included in clinical trials. 1) Preoperative fine or coarse needle aspiration suggestive of non-PTC patients. 2) History of thyroid or parathyroid surgery, or other neck surgery. 3) history of radioactive iodine treatment. 4) history of previous external radiation to the neck. 5) abnormal preoperative parathyroid hormone or serum calcium levels 6) liver, kidney and other organ dysfunction. 7) Pregnant and lactating women (female patients are routinely excluded by urine pregnancy tests). 8) Those who cannot tolerate the procedure for various reasons. 9) Those whose baseline data cannot be fully collected. 10) Those whose surgical scope is less than total thyroid dissection. 11) Those deemed unsuitable for enrollment by the investigator. 12) Subjects with poor compliance and unwillingness to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parathyroid function;PTH; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor recurrence rate;Number of lymph node dissection in the central region of the neck;Length of surgery and complications;TSH;TgAb; | — |
Countries
China
Contacts
Public ContactSuanping
West China Hospital, Sichuan University
Outcome results
None listed